Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1
NCT ID: NCT05219864
Last Updated: 2022-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2023-01-31
2024-09-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ruxolitinib
Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.
Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle
Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.
Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.
Interventions
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Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Screening and baseline IGA-CHE 3 or 4.
* Baseline CHE-related Itch NRS ≥ 4.
* Recent history (within the past 1 year of baseline) of inadequate response to treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or oral alitretinoin; or intolerance or contraindication to TCS or TCI or oral alitretinoin.
* Willingness to avoid pregnancy or fathering children based on the criteria below.
Exclusion Criteria
* Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
* Participants with concurrent conditions and history of other diseases such as other active skin disease or infection on the hands; immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with study assessments or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids; current or history of hepatitis B or C virus infection.
* Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
* Laboratory values outside of the protocol-defined criteria.
* Use of protocol-defined treatments within the indicated washout period before baseline.
* Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline.
* Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
18 Years
99 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Haq Nawaz, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Southwest Skin Specialists Phoenix Biltmore
Phoenix, Arizona, United States
Raoof Md Encino
Encino, California, United States
First Oc Dermatology
Fountain Valley, California, United States
Marvel Clinical Research Llc
Huntington Beach, California, United States
Well Pharma Medical Research Corporation
Miami, Florida, United States
Psoriasis Treatment Center of South Florida
Pembroke Pines, Florida, United States
Lenus Research Medical Group, Llc
Sweetwater, Florida, United States
Delricht Research
Marietta, Georgia, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Midwest Allergy Sinus Asthma, Sc
Springfield, Illinois, United States
Dermatologist Specialist
Louisville, Kentucky, United States
Grafton Dermatology and Cosmetic Surgery
Houma, Louisiana, United States
Delricht Research
New Orleans, Louisiana, United States
Washington University
St Louis, Missouri, United States
Jubilee Clinical Research Inc
Las Vegas, Nevada, United States
Juva Skin and Laser Center
New York, New York, United States
Oregon Medical Research Center
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center
Memphis, Tennessee, United States
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, United States
Austin Institute For Clinical Research Aicr Pflugerville
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Center For Clinical Studies Webster
Webster, Texas, United States
University of Utah
Murray, Utah, United States
West End Dermatology Associates
Richmond, Virginia, United States
Dermatology Specialists of Spokane
Spokane, Washington, United States
Dermatology Research Institute Inc.
Calgary, Alberta, Canada
Care Clinic
Red Deer, Alberta, Canada
Cca Medical Research
Ajax, Ontario, Canada
Lynderm Research Inc
Markham, Ontario, Canada
Fakultni Nemocnice U Sv. Anny V Brne
Brno, , Czechia
Ccr Ostrava S.R.O.
Ostrava, , Czechia
Ccr Czech A.S.
Pardubice, , Czechia
Clintrial S.R.O.
Prague, , Czechia
Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.
Ústí nad Labem, , Czechia
Klinikum Der Johann Wolfgang Goethe-Universitaet
Frankfurt, , Germany
Derma-Study-Center Friedrichshafen Gmbh
Friedrichshafen, , Germany
Dermatologikum Hamburg Gemeinschaftspraxis Gbr
Hamburg, , Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, , Germany
Praxis Dr. Beate Schwarz
Langenau, , Germany
Beldio Research Gmbh
Memmingen, , Germany
Klifos - Klinische Forschung Osnabruck
Osnabrück, , Germany
Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
Elblag, , Poland
Etg Warszawa
Warsaw, , Poland
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital de Manises
Manises, , Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, , Spain
Countries
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Other Identifiers
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INCB 18424-313
Identifier Type: -
Identifier Source: org_study_id
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